Water

Description

Sterile Water for Injection is a sterile, non-pyrogenic preparation intended for use as a diluent or solvent for parenteral drugs. It is packaged in accordance with the United States Pharmacopeia (USP) standards. The product is supplied in a carton labeled with the National Drug Code (NDC) 62135-833-84. This formulation is characterized by its clarity and absence of particulate matter, ensuring suitability for injection purposes.

Uses and Indications

Sterile Water for Injection is indicated as a diluent or solvent for the preparation of parenteral solutions. This product is intended for use in healthcare settings where sterile conditions are maintained to ensure the safety and efficacy of injectable medications.

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with the use of Sterile Water for Injection. However, it is essential to follow appropriate guidelines for the preparation and administration of parenteral solutions to ensure patient safety.

Dosage and Administration

Sterile Water for Injection is intended exclusively for parenteral use and must only be utilized after the addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. This preparation is specifically indicated for the dilution or dissolution of drugs intended for intravenous, intramuscular, or subcutaneous injection, in accordance with the manufacturer's instructions for the drug being administered.

Prior to use, Sterile Water for Injection must be rendered approximately isotonic. Healthcare professionals should consult the manufacturer's instructions to determine the appropriate choice of vehicle, dilution, or volume necessary for dissolving the drugs to be injected, including the specified route and rate of injection. The volume of Sterile Water for Injection utilized for diluting or dissolving any drug is contingent upon the vehicle concentration, dosage, and route of administration as recommended by the manufacturer.

The routes of administration include intravenous, intramuscular, and subcutaneous. Aseptic technique must be employed when withdrawing from the container. When diluting or dissolving drugs, it is essential to mix thoroughly and use the preparation promptly. Reconstituted solutions of drugs for injection should not be stored unless explicitly directed by the manufacturer of the solute. Prior to administration, reconstituted (diluted or dissolved) drugs must be inspected for clarity (if soluble) and checked for any unexpected precipitation or discoloration.

Contraindications

Intravenous injection is contraindicated unless the osmolar concentration of additives results in an approximate isotonic admixture. Reconstituted solutions of drugs for injection should not be stored unless specifically directed by the manufacturer of the solute. The solution must be clear prior to use; do not use if it is not. Single-dose containers are not to be reused; any unused portion should be discarded.

Warnings and Precautions

Intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis. It is imperative that this solution is not used for intravenous injection unless the osmolar concentration of any additives results in an approximately isotonic admixture. Potential reactions associated with this solution, added drugs, or the reconstitution and administration techniques may include febrile responses, local tenderness, abscess formation, tissue necrosis, infection at the injection site, venous thrombosis, phlebitis extending from the injection site, and extravasation. This parenteral preparation is generally not expected to pose a risk of fluid overload, except in neonates or very small infants.

Animal reproduction studies have not been conducted with Sterile Water for Injection, and it remains unclear whether sterile water containing additives can cause fetal harm when administered to pregnant women or affect reproductive capacity. Therefore, Sterile Water for Injection with additives should only be administered to pregnant women when clearly necessary. While safety and effectiveness have been established in pediatric patients, caution is advised in neonates or very small infants, as the volume of fluid may impact fluid and electrolyte balance.

Healthcare professionals should be aware that some injectable drugs may exhibit incompatibility when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consultation with a pharmacist is recommended when necessary. Aseptic technique must be employed when withdrawing from the container. When diluting or dissolving drugs, thorough mixing and prompt use are essential. Reconstituted solutions of drugs for injection should not be stored unless specifically directed by the manufacturer of the solute, and only clear solutions should be utilized. Single-dose containers must not be reused, and any unused portion should be discarded.

Prior to administration, reconstituted drugs should be inspected for clarity and freedom from unexpected precipitation or discoloration. The parenteral solution itself should also be visually inspected for particulate matter and discoloration whenever the solution and container permit.

In the event of an adverse reaction, it is crucial to discontinue the infusion, evaluate the patient, and implement appropriate countermeasures. If possible, the remainder of the unused vehicle should be retrieved and saved for examination. Should fluid overload occur, a re-evaluation of the patient is necessary, followed by the implementation of appropriate corrective measures.

Side Effects

Patients receiving this solution may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions associated with the administration of this solution include febrile responses, local tenderness, abscess formation, tissue necrosis or infection at the injection site, venous thrombosis, phlebitis extending from the site of injection, and extravasation. These reactions may arise due to the solution itself, added drugs, or the technique of reconstitution or administration.

Additionally, intravenous administration of Sterile Water for Injection without a solute has been noted to potentially result in hemolysis. It is important to consider that when Sterile Water for Injection is utilized solely as a pharmaceutical aid for diluting or dissolving drugs for parenteral injection, the volume of fluid provided is unlikely to significantly affect fluid balance, except in neonates or very small infants. In cases of fluid overload, it is essential to re-evaluate the patient and implement appropriate corrective measures.

Drug Interactions

Certain injectable medications may exhibit incompatibility when combined in a specific vehicle, particularly those containing benzyl alcohol. It is advisable to consult with a pharmacist to ensure safe and effective administration of these drugs. Monitoring for potential adverse effects is recommended when administering these combinations, and appropriate adjustments should be made based on professional guidance.

Packaging & NDC

The table below lists all NDC Code configurations of Sterile Water, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants, the volume of fluid administered may impact fluid and electrolyte balance. While this parenteral preparation is generally unlikely to cause fluid overload, caution is advised in these populations. If fluid overload occurs, it is essential to re-evaluate the patient and implement appropriate corrective measures.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential effects of sterile water containing additives on fetal harm or reproductive capacity in pregnant patients are not known. Therefore, Sterile Water for Injection with additives should be administered to pregnant women only if clearly needed, taking into consideration the potential risks versus benefits.

Lactation

Sterile Water for Injection has not been studied in animal reproduction studies, and it is unknown whether it can be excreted in human breast milk or if it poses any risk to breastfed infants. Therefore, lactating mothers should exercise caution when considering the use of Sterile Water for Injection with additives.

While safety and effectiveness have been established in pediatric patients, special attention should be given to neonates or very small infants, as the volume of fluid administered may impact their fluid and electrolyte balance. It is advisable for lactating mothers to consult healthcare professionals before using this product, particularly in the context of breastfeeding.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of Sterile Water for Injection, USP. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions indicated for this population. Healthcare professionals should exercise clinical judgment when considering the use of this product in patients with compromised liver function, as individual patient factors may influence treatment outcomes.

Overdosage

Intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis. It is imperative that this preparation is not used for intravenous injection unless the osmolar concentration of any additives results in an approximately isotonic admixture.

While this parenteral preparation is generally not associated with a significant risk of fluid overload, caution is advised in neonates or very small infants. In cases where fluid overload is suspected, a thorough re-evaluation of the patient is necessary, and appropriate corrective measures should be instituted promptly to mitigate any potential complications.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with Sterile Water for Injection. The potential for sterile water containing additives to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, Sterile Water for Injection with additives should be administered to a pregnant woman only if clearly needed.

Safety and effectiveness have been established in pediatric patients. However, in neonates or very small infants, the volume of fluid may impact fluid and electrolyte balance.

Postmarketing Experience

Reactions reported in postmarketing experience include febrile response, local tenderness, abscess, tissue necrosis, or infection at the injection site, as well as venous thrombosis or phlebitis extending from the injection site and extravasation. In cases where an adverse reaction occurs, it is recommended to discontinue the infusion, evaluate the patient, and implement appropriate countermeasures. If feasible, the remainder of the unused vehicle should be retrieved and preserved for examination.

This parenteral preparation is generally not associated with a significant risk of fluid overload, except potentially in neonates or very small infants. Should fluid overload occur, it is advised to re-evaluate the patient and take necessary corrective measures.

Patient Counseling

Healthcare providers should advise patients that Sterile Water for Injection must be made approximately isotonic prior to use to prevent potential complications. It is critical to inform patients that intravenous administration of Sterile Water for Injection without a solute may lead to hemolysis, a serious condition that can occur if the osmolar concentration of additives does not result in an isotonic admixture.

Providers should emphasize the importance of consulting the manufacturer’s instructions regarding the choice of vehicle, appropriate dilution, or volume for dissolving the drugs to be injected, including the recommended route and rate of injection. Patients should be instructed to inspect reconstituted drugs for clarity and to ensure there is no unexpected precipitation or discoloration prior to administration.

Aseptic technique must be used when withdrawing from the container, and patients should be reminded to mix thoroughly and use the solution promptly when diluting or dissolving drugs. It is essential to inform patients not to store reconstituted solutions of drugs for injection unless specifically directed by the manufacturer of the solute, and to only use solutions that are clear.

Healthcare providers should counsel patients against reusing single-dose containers and advise them to discard any unused portions. Patients should be made aware of potential reactions that may occur due to the solution, added drugs, or the technique of reconstitution or administration. These reactions can include febrile response, local tenderness, abscess, tissue necrosis or infection at the injection site, venous thrombosis, phlebitis extending from the injection site, and extravasation.

In the event of an adverse reaction, healthcare providers should instruct patients to discontinue the infusion, evaluate their condition, and implement appropriate countermeasures. If possible, the remainder of the unused vehicle should be retrieved and saved for examination.

Patients should be informed that this parenteral preparation is unlikely to pose a threat of fluid overload, except possibly in neonates or very small infants. In such cases, re-evaluation and appropriate corrective measures should be instituted. The volume of the preparation used for diluting or dissolving any drug for injection will depend on the vehicle concentration, dose, and route of administration as recommended by the manufacturer. Finally, patients should be advised to visually inspect the parenteral solution for particulate matter and discoloration prior to administration whenever the solution and container permit.

Storage and Handling

The product is supplied in single-dose containers, which should not be reused. It is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F). Aseptic technique must be employed when withdrawing the solution from the container to ensure sterility.

Any unused portion of the product should be discarded. Reconstituted solutions of drugs for injection should not be stored unless specifically directed by the manufacturer of the solute. Additionally, the solution must be clear prior to use; any solution that appears cloudy should not be utilized.

Additional Clinical Information

Patients receiving the medication should be administered via intravenous, intramuscular, or subcutaneous routes. Clinicians are advised to employ aseptic techniques when withdrawing the drug from its container. It is essential to mix any diluted or dissolved drugs thoroughly and use them promptly. Prior to administration, the reconstituted solutions must be inspected for clarity and checked for any unexpected precipitation or discoloration. Reconstituted solutions should not be stored unless specifically directed by the manufacturer, and only clear solutions should be used. Additionally, single-dose containers must not be reused, and any unused portions should be discarded.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Sterile Water as submitted by Chartwell RX, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)